Medical device companies doing business in the European Union (EU) should start planning for the coming years.
Yesterday, the European Parliament (EP) approved the proposed regulations on medical devices (MDR) and on in-vitro diagnostic medical devices (IVDR). The EP’s approval concludes a legislative process that lasted over four years, since the original proposal by the European Commission (EC) in September 2012. The new regulations will enter into force 20 days after their publication in the Official Journal of the European Union next month. A transitional period for manufacturers to adapt to the new requirements will last for three years (for the MDR) and five years (for the IVDR) from the date of entry into force.
The regulations introduce provisions that aim at improving the quality, safety and reliability of medical devices, strengthening transparency of information to consumers, and enhancing vigilance and market surveillance. These include stricter premarket review of high-risk devices (such as implants, joint replacements or insulin pumps), strengthened designation criteria for notified bodies, improved traceability, as well as a risk-based classification system for IVDs.
The regulations will replace the current framework set forth by the three EU medical device directives (90/385/EEC; 93/42/EEC; and 98/79/EC), implemented in each EU member state through national legislation. Importantly, the regulations will introduce a single regulatory framework that will apply throughout the EU, thereby reducing the role of member states in policy-making and the existing regulatory inconsistencies in the EU medical device sector.
The new regulations will inevitably entail additional burdens for companies, which everyone hopes will be compensated by a better protection of public health and patient safety in the EU. It can be expected, however, that compliance costs will decrease over time as a consequence of the enhanced regulatory harmonisation. It will be key for companies to manage the transition efficiently to ensure a smooth shift to the new framework.
The MDR and IVDR are also likely to have an impact on medical device companies beyond the EU. On the one hand, the new EU rules may have an indirect effect in those markets where the local regulator (partly) relies on the EU CE-mark certification to register medical devices in the local market (such as, to a varying extent, Australia, Iran, Jordan, Lebanon, Saudi Arabia, Turkey and the United Arab Emirates). On the other hand, it can be expected – as the EC hopes – that the new EU framework will influence the development of medical device regulation on a global scale.